An Efficacy and Safety Study of ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

• Conditions: Agitation and Aggression in Moderate to Severe Alzheimer's Disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004299-20-ES
• Lead Sponsor: Elan Pharma International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-06
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

-Has a diagnosis of Probable AD according to the updated National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; 'McKhann II') Criteria.

-Has an MMSE score of 10 to 21 (inclusive) at the Screening Visit.

-Has clinically significant agitation/aggression defined as NPI agitation/aggression subscore of >= 4, with a severity score of >= 2 at both the Screening and Baseline Visits.

-Has had either no response or suboptimal response to standard nonpharmacological interventions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

-The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.

-Has a current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition Text Revision (DSM IV TR).

-Has symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization.

-Treated with oral antipsychotic medications within 2 weeks prior to the Screening Visit.

-Treated with depot preparations of an antipsychotic within 3 months of the Screening Visit.

-Has Screening Visit brain MRI scan abnormalities that can be attributed to diseases or processes other than AD.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of ELND005 treatment compared with placebo in reducing the severity of agitation and aggression at 12 weeks; <br>To evaluate the safety and tolerability of the ELND005 dosing regimen in Moderate to Severe AD patients;Secondary Objective: To evaluate additional efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.<br><br>To evaluate the efficacy of ELND005 on the patient's dependence status and on caregiver distress.<br><br>To evaluate the effects of the ELND005 dosing regimen on the incidence of brain amyloid-related imaging abnormalities;Primary end point(s): The difference in change from Baseline to Week 12 in NPI-C combined agitation and aggression subscores between the ELND005 and placebo treatment groups;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from Baseline in:<br>- mADCS-CGIC agitation domain scores<br>- NPI-C subitems of agitation, aggression, apathy, depression/dysphoria, anxiety <br>-NPI subitems of aberrant motor behavior, nighttime behavior, disinhibition, delusions, and hallucination<br>- Total NPI score;Timepoint(s) of evaluation of this end point: Week 12